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Enrolling By Invitation NCT04957719

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

Conditions: Acute Myocardial Infarction

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 25000
Sponsor: Viatris Innovation GmbH

Location: Advanced Cardiovascular, LLC Alexander City Alabama

Summary

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

Eligibility Criteria

Main Inclusion Criteria: * Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization. * Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors: * Second prior AMI, * Diabetes mellitus defined by ongoing glucose lowering treatment, * Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage, * Peripheral artery disease at any time prior to randomization, * Absence of, or unsuccessful coronary revascularization of the qualifying AMI. * Successful self-administered placebo according to the autoinjector instruction for use training during screening. Main Exclusion Criteria: * Increased risk of serious bleeding including any of the following: * History of intracranial bleed at any time. * Known uncorrected intracranial vascular abnormality. * Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening. * Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant). * Known liver impairment significantly affecting the hepatic function. * Current dialysis. * Ischemic stroke or transient ischemic attack within 3 months of screening. * Chronic anemia with hemoglobin \< 10 g/dL. * Chronic thrombocytopenia with platelet count \< 100,000/mm3. * Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class. * Previous exposure to an investigational drug within 3 months prior to randomization. * Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04957719). StuddyBuddy aggregates publicly available trial information.